K242954 is an FDA 510(k) clearance for the Integrity V500 (Integrity, Integrity with VEMP). This device is classified as a Stimulator, Auditory, Evoked Response (Class II - Special Controls, product code GWJ).
Submitted by Vivosonic, Inc. (Toronto, CA). The FDA issued a Cleared decision on December 19, 2024, 85 days after receiving the submission on September 25, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.1900.
| 510(k) Number | K242954 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2024 |
| Decision Date | December 19, 2024 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | GWJ - Stimulator, Auditory, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1900 |